At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
Miltenyi CliniMACS® CD34 Reagent Systemdevice
Likely dose
Miltenyi CliniMACS® CD34 Reagent System — CD34+ enriched/T-cell depleted cells from haploidentical mobilized peripheral blood combined with single unit umbilical cord bloodAI-extracted
Key inclusion· 5
- ✓Ages 18–80 years inclusive
- ✓Diagnosed with high-risk hematologic disorder warranting stem cell transplant per institutional standard of care
- ✓Lack HLA-identical related donor
- ✓Availability of at least one HLA-haploidentical (≥5/10 and ≤8/10 HLA match) related donor able to donate CD34+ cells
Key exclusion· 2
- ✕HLA-identical (6/6) related donor available and readily accessible at time of transplantation evaluation
- ✕Does not meet institutional standard guidelines for transplant eligibility
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Miltenyi CliniMACS® CD34 Reagent System for Transplant Protocol Utilizing Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
In Brief
A clinical study evaluating Miltenyi CliniMACS® CD34 Reagent System for Hematologic Disorders. Completed, enrolled 150 participants across 1 site.
Detailed Summary
This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent System to promote engraftment of haploidentical CD34+ selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Disorders
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartOct 2017
Primary CompletionNov 2024
Study CompletionFeb 2025
TodayJul 2026
First PostedMar 28, 2017
Enrollment StartOct 12, 2017
Primary CompletionNov 27, 2024
Study CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 9.3 years ago
Interventions
Miltenyi CliniMACS® CD34 Reagent Systemdevice
Miltenyi CliniMACS® CD34 Reagent System will be used to prepare CD34+ enriched/T-cell depleted cells from haploidentical mobilized peripheral blood.